In the early 1970s, I was a young nurse working with many trauma victims in a state-of-the-art intensive care unit and I loved it. Because of the high number of young accident victims, I was also often involved with organ donation from patients diagnosed as brain-dead. Asking shocked and grieving relatives about organ donation was the hardest part of my work.

Back then, "brain death" was a new legal and ethical concept stemming from an influential 1968 Harvard medical school committee paper titled "A Definition of Irreversible Coma", which concluded that severely brain-injured patients who met certain criteria could be pronounced dead before the heart stops beating. Starting in the early 1970s, various state legislatures and courts acted to turn this "medical consensus" into a legally recognized standard for determining death by loss of all brain function. Patients declared "brain-dead" then could have their organs harvested while their hearts were still beating and a ventilator kept their lungs going. The brain death concept virtually created the modern transplant system because waiting to take organs until breathing and heartbeat naturally stopped usually resulted in unusable, damaged vital organs.

Like most people, I didn't know the history of brain death back then and despite the tragic circumstances of my "brain-dead" patients, I was excited by the opportunity to participate in turning tragedy into the "gift of life".

Over time, however, I developed some nagging concerns about the brain-death concept and I shared them with our intensive care doctors. I was told, as one doctor put it, "Nancy, greater minds than yours have already figured this all out so don't worry about it." It took me years to realize that this meant these doctors didn't know the answers either.

Death and Choice

Unknown to most people, controversy about brain death has simmered for years in the bioethics community. Some well-known physicians, for example, Alan Shewmon and Paul Byrne, argue that the current brain-death standard does not reflect true death. Others, such as Dr. Ron Cranford and ethicist Robert Veatch, argue that the brain-death standard should be stretched to include so-called "persistent vegetative" patients, further expanding the pool of potential organ donors.

Last August the bioethics world was rocked by an article by Drs. Robert Truog and Franklin G. Miller in the prestigious New England Journal of Medicine that made the shocking assertion that many organ donors were not really dead at the time their vital organs were harvested.1
This Harvard doctor and this National Institutes of Health bioethicist then proposed the radical idea that doctors should drop the rule requiring that people be declared dead before vital organs are taken in favor of merely "obtaining valid informed consent for organ donation from patients or surrogates before the withdrawal of life-sustaining treatment in situations of devastating and irreversible neurologic injury". This, in Truog's and Miller's opinion, would preserve the current transplant system and still be acceptable to the public because "issues related to respect for valid consent and the degree of neurologic injury may be more important to the public than concerns about whether the patient is already dead at the time organs are removed."

Perhaps as a result of articles like this, the President's Council on Bioethics decided to explore the determination-of- death issues involved in organ transplantation. In January 2009, the Council published "Controversies in the Determination of Death: A White Paper".2
Many of the report's consensus conclusions were surprising and controversial themselves.

The President's Council on Bioethics White Paper

The President's Council on Bioethics white paper on the determinations of death made several startling admissions, including finding that some of the most fundamental rationales for brain death were wrong. The Council, citing scientific studies and observations, admitted that the brain is apparently not the central organizing agent without which the body cannot function for more than a short period of time. Years ago, many of us questioned why some supposedly brain-dead pregnant women could be maintained on ventilators - for even up to a couple of months in some cases - in order to help their unborn children develop and survive birth. Others observed that some supposedly brain-dead children could actually grow and even sexually mature if maintained on life support. It turns out that we were right to question this allegedly settled matter.

The Council also had to admit the little-known fact that brain-death tests vary widely from institution to institution, potentially leading to people who could be declared brain-dead at one hospital but at a different hospital still be considered alive. Personally, I was disappointed that the Council's paper did not even mention instances like the recent Zach Dunlap case, in which every supposedly definitive brain-death test was done, but a last-minute response by Zach stopped the impending organ donation and Zach even recovered.3

But in the consensus opinion of the Council members, apparently the concept of brain death is just too big to fail. Accordingly, some members of the Council proposed that the term "brain death" be replaced with the term "total brain failure". And with the new term, these members created a new justification for harvesting the organs of people declared to have this condition. According to this redefinition, the brain is important not because it controls physiological processes, but because these processes represent "engagement with the world".

This "engagement with the world" takes three forms: openness to the world, an ability to act on the world, and the need to do so. These abstract requirements can be met by something as basic as breathing but they are not met by physiological activities that continue in people who have allegedly lost all neurological function. This, the Council members insisted, is enough to spare breathing, brain-injured people like Terri Schiavo from a diagnosis of "total brain failure". Ironically though, this assertion does not protect people like Terri from having vital organs removed during the time when they are initially placed on a ventilator because doctors can then use another, newer determination of death called "donation after cardiac death" or DCD (formerly known as "non-heartbeating organ donation" or NHBD).4
The Council's white paper also addresses this type of death determination and, in the process, makes more startling admissions.

DCD/NHBD was developed in the early 1990s to promote a newer standard of determining death for the purpose of organ donation. DCD/NHBD describes a procedure in which a person is declared hopelessly brain-injured or ill but not brain-dead and, with the consent of the patient or surrogates (or potentially even a "living will"-style document), has his or her ventilator removed with the expectation that breathing and heartbeat will stop within about 1 hour. When the heartbeat and breathing stop for usually about 2 to 5 minutes, the person is declared dead and the organs are taken for transplant. If the person's heartbeat and breathing do not stop within the allotted time, the transplant is called off and the person is left to die without further treatment.

The Council's white paper admitted that the legal definition of irreversible cessation of heartbeat and breathing used to justify DCD/NHBD has problems. Most people would consider "irreversible" in this context to mean that the heart has lost the ability to beat. But in DCD/NHBD, "irreversible" instead means that there is a deliberate decision not to try to restart the heart when it stops and that enough time has elapsed to ensure that the heart will not resume beating on its own. However the Council had to admit the dearth of scientific evidence supporting this determination. In some cases involving babies, for instance, the heart is harvested and actually restarted in another baby.

The Council also admitted that even fully conscious but spinal-cord-injured patients have become DCD/NHBD donors when dependent on a ventilator. This sad fact is the result of virtually all withdrawal-of-treatment decisions now being considered legal and thus ethical.

The Council also noted that even though doctors are advised to take their time determining death when a natural death occurs, the interval between declaring death and starting transplantation in a DCD/NHBD patient has been as short as 75 seconds. It seems obvious that the push for a speedy declaration of death is not about new scientific information determining the moment of death but rather a desire to quickly get organs because "[t]he longer a patient removed from ventilation Ôlingers' before expiring, the more likely are the organs destined for transplantation to be damaged by warm ischemia [lack of adequate blood flow]".5
But even while expressing concerns, the Council still supported the DCD/NHBD concept in the end.

Despite pages discussing these DCD/NHBD issues, the Council unfortunately ignored a most crucial issue: How do doctors determine who is a "hopeless enough" patient with functioning vital organs and who will also die fast enough to get usable organs? The Council never mentioned articles like the one in the September/October 2008 issue of the Journal of Intensive Care Medicine, which stated "Donation failure [patients who don't die fast enough to have usable organs] has been reported in at least 20% of patients enrolled in DCD". Those authors also concluded that "There is little evidence to support that the DCD practice complies with the dead donor rule".6

We Are All Affected

While organ donation is a worthy goal when conducted ethically, it is very dangerous when physicians and ethicists redefine terms and devise new rationales without the knowledge or input of others, especially the public. This has been happening far too often and far too long in many areas of medical ethics and the consequences are often lethal.

Opinions about medical ethics affect all of us and our loved ones. And good medical ethics decisions are the foundation of a trustworthy medical system. We are constantly exhorted to sign organ-donor cards and join state organ registries but are we getting enough accurate information to give our truly informed consent? This question is too important to just leave to the self-described experts.